FDA.reportPublic FDA data

Application 079025

Type
ANDA
Sponsor
EMCURE PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEFOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDETABLET;ORAL10MG;12.5MGNoNo
002FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEFOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDETABLET;ORAL20MG;12.5MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-060Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and Hydrochlorothiazide TabletHeritage Pharmaceuticals Inc.ANDACurrent
23155-060Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-061Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-061Fosinopril Sodium and HydrochlorothiazideFosinopril Sodium and HydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent